A requirement for submitting clinical trial results to regulatory authorities is to map the raw trial data into CDISC SDTM (Standard Data Tabulation Model) domains. After over 30 years in the industry, I have become a specialist in this process and have recently earned my CDISC Tabulate Certification in 2021. I have provided training to programmers, data managers and biostatisticians across the world, as well as working directly on dozens of projects over the last 17 plus years, resulting in many successful US FDA and rest-of-world regulatory authority submissions. My primary responsibility is oversight of our North American-based programming team, who collectively have decades of experience in CDISC SDTM mapping in clinical trials. As a full service CRO, PROMETRIKA works on studies where we are the only CRO and where multiple CROs are working on different parts of the trial, such as data management, clinical operations, or statistics. Studies with multiple CROs require a high degree of communication and collaboration with the client across the involved organizations.
Recently, while performing CDISC SDTM mapping for one of our clients, a unique situation arose that involved the DA (Drug Accountability) domain. This domain tabulates the amount of treatment units dispensed to a subject and the amount returned to gauge dosing compliance for each treated subject and is often collected in a log format. On the surface, it seems like a fairly straight forward domain, but for this particular example, there were a number of factors that contributed to creating a complex scenario. First, there was an outside CRO responsible for data management who built the EDC system and cleaned the data. Then, the study protocol was amended several times, including the addition of an open label extension which required a separate database from that for the double-blind portion of the study. In addition, the drug accountability data was collected in the EDC databases using a combination of a data pull from IWRS (Interactive Web Response Systems) and keyed entry. After reviewing the initial related data analysis outputs, identified inconsistencies and overlapping data made it apparent that an unusual approach was required to tabulate the data into a clearer structure. After collaborating with the client to better understand the raw data structure, we crafted a workable and conformant solution.
A search of the literature revealed that there are no published papers or presentations specifically on the DA domain, until now. I am excited to announce that at the upcoming PharmaSUG (Pharma SAS Users Group) 2023 conference in San Francisco, I will present my paper, “As Simple as Falling Off a Log?: An Unusual Case Study of Mapping Data into the SDTM DA (Drug Accountability) Domain” on Monday, May 15th at 4:30 pm PT, which describes the issues and solution in more detail. Please join my presentation in person or watch this space to find a link to read the published paper in its entirety. If you need CDISC SDTM mapping services, simple to complex, our expert statistical programming team can help.